Mintz Levin - Health Law & Policy Matters

Just in Time for the Phase II Audits: OIG Criticizes OCR’s Enforcement Efforts

As HIPAA-regulated entities anxiously await the commencement of the Phase II HIPAA audit program, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has issued a report critical of…more
| Consumer Protection, Health, Privacy

CMS Publishes Long-Awaited PAMA Proposed Rule

On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule (MCLFS)…more
| Health, Science, Computers, & Technology

“Two-Midnight” Rule Needs Tweaking, Says Federal Judge

A Federal Judge found that the Department of Health and Human Services (DHHS) failed to comply with the Administrative Procedure Act (APA) when it cut hospital inpatient payments by 0.2% as part of its “two-midnight” rule. …more
| Civil Procedure, Health

DOJ Clarifies Position on Individual Accountability in Corporate Investigations

Earlier this month, we discussed a memorandum issued by Deputy Attorney General Sally Quillian Yates of the U.S. Department of Justice (DOJ). This memorandum, referred to as the “Yates Memo,” reaffirms the Government’s…more
| Business Organizations, Commercial Law & Contracts, Criminal Law, Health

Mintz Levin Health Care Qui Tam Update: Recent Developments & Unsealed Cases - September 2015

Trends & Analysis - Since our last Qui Tam Update, we have identified 39 health-related False Claims Act (“FCA”) qui tam cases that have been unsealed. Of those cases..…more
| Civil Procedure, Government Contracting, Health, Labor & Employment Law

Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and…more
| Elections & Politics, Health, Science, Computers, & Technology

Medicare to Permit Value-Based Insurance Design in Medicare Advantage Plans

The Centers for Medicare & Medicaid Services (“CMS”) recently announced that, beginning January 1, 2017, Medicare Advantage plans in Arizona, Indiana, Iowa, Massachusetts, Oregon, Pennsylvania and Tennessee will be permitted to…more
| Health

Exellus BlueCross BlueShield – Latest Victim of a “Sophisticated” Health Plan Cyberattack

Exellus BlueCross BlueShield has announced that the personal information of at least 10 million members has been compromised in a “very sophisticated” cyberattack that occurred on December 23, 2013 and was discovered by the plan…more
| Consumer Protection, Privacy, Science, Computers, & Technology

DOJ Issues Memo Directing Prosecutors to Focus on Individual Accountability

The U.S. Department of Justice (DOJ) issued a memorandum on Wednesday from Deputy Attorney General Sally Quillian Yates that reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to…more
| Business Organizations, Criminal Law

Drastic Changes Proposed for Clinical Research Rules

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common Rule,”…more
| Health, Science, Computers, & Technology

FDA’s New Four-Letter Guidance on Biosimilars

After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products. The…more
| Consumer Protection, Science, Computers, & Technology

Back to School – HIPAA 101

After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security. Here are four…more
| Consumer Protection, Health, Labor & Employment Law, Privacy, Science, Computers, & Technology

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to…more
| Consumer Protection, Elections & Politics, Health, Science, Computers, & Technology

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided…more
| Administrative Law, Communications & Media Law, Government Contracting, Health, Science, Computers, & Technology

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained a…more
| Administrative Law, Communications & Media Law, Constitutional Law, Health, Science, Computers, & Technology
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701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States

  • 202-434-7324
  • 202-434-7400

Areas of Practice
  • Administrative Law
  • Commercial Law & Contracts
  • Health
  • Litigation
  • Mergers & Acquisitions
  • Securities Law
Other U.S. Locations
  • California
  • Connecticut
  • D.C.
  • Massachusetts
  • New York
Other Countries
  • Israel
  • United Kingdom
Number of Attorneys

25-50 Attorneys

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